Sex Hormones and Orthostatic Tolerance

Brief Title

Sex Hormones and Orthostatic Tolerance

Official Title

Sex Hormones and Orthostatic Tolerance

Brief Summary

      This study is designed to determine the causes of "orthostatic intolerance" which occurs more
      commonly in women than in men. Orthostatic tolerance is the ability to remain standing up
      right for long periods of time, or to avoid dizziness when moving to standing from a seated
      or lying position.
    

Detailed Description

      In this study we are interested in determining the impact of female reproductive hormones
      (estrogen and progesterone) on orthostatic tolerance (described above) so we administer these
      hormones to participants. We also test participants' orthostatic tolerance in our laboratory
      and use this information to place subjects into groups.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Orthostatic Tolerance


Condition

Orthostatic Intolerance

Intervention

Ganirelix acetate

Study Arms / Comparison Groups

 Ganirelix acetate
Description:  Subjects were given 250 μg in 0.5ml normal saline for 16 days. (Organon, Roseland, NJ, USA)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

109

Start Date

February 2006

Completion Date

May 2013

Primary Completion Date

December 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy, English-speaking non-smoking women age 18- 34 with regular menses

        Exclusion Criteria:

          -  Gynecologic:

               1. current or past estrogen-dependent neoplasia,

               2. unexplained vaginal bleeding,

               3. history of uterine fibroids,

               4. current pregnancy,

               5. known or suspected breast or uterine cancer,

               6. partial or complete hysterectomy

          -  Cardiac:

               1. myocardial infarction, ventricle tachycardia or fibrillation,

               2. angina,

               3. valvular disease,

               4. congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea,

               5. current arrhythmias,

               6. prosthetic valves

          -  Pulmonary:

               1. current cigarette smokers, or pipe or cigar smokers,

               2. chronic obstructive pulmonary disease,

               3. adult asthma,

               4. dyspnea on exertion,

               5. current bronchitis, pneumonia, or tuberculosis,

               6. lung carcinoma,

               7. pulmonary embolus, recent

          -  Vascular:

               1. claudication or history of peripheral vascular disease,

               2. abdominal or thoracic aortic aneurysm, or repair of same,

               3. cerebral aneurysm, vascular malformations,

               4. hypertension, systolic or diastolic, or strong family history of hypertension

          -  Gastrointestinal:

               1. GI malignancy,

               2. hepatitis, current,

               3. splenomegaly from any cause,

               4. Cholecystitis,

               5. current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative
                  colitis, Crohn's Disease,

               6. previous gastrointestinal surgery

          -  Infectious Disease: any intercurrent infection

          -  Hematologic/Oncologic:

               1. receiving chemotherapy or radiation therapy,

               2. any metastatic malignancy,

               3. anemia (hematocrit < 35),

               4. thrombocytopenia or thrombocytosis,

               5. neutropenia,

               6. hematologic malignancy,

               7. bleeding dyscrasia

          -  Neurologic:

               1. history of cerebral vascular accident with any neurologic sequels,

               2. uncontrolled seizures (e.g. more than 1 seizure/year),

               3. transient ischemic attacks,

               4. dementia,

               5. neurologic conditions producing dyscoordination, peripheral neuropathy, or
                  myopathy,

               6. severe migraine headaches

          -  Endocrine:

               1. diabetes mellitus,

               2. any untreated endocrinopathy

          -  Renal:

               1. chronic renal disease,

               2. any history of renal disease or impairment,

               3. current urinary tract infection

          -  Musculoskeletal:

               1. inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters),

               2. any history of pathologic fractures, including vertebral compression fractures

          -  Pharmacologic:

               1. any illegal drug use,

               2. alcohol use greater than an average of 4 oz/day over 30 days,

               3. coumadin or heparin use,

               4. current systemic antifungal use
      

Gender

Female

Ages

18 Years - 34 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Nina Stachenfeld, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01153581

Organization ID

0512000875a

Secondary IDs

2R01HL071159-04

Responsible Party

Sponsor

Study Sponsor

Yale University

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Nina Stachenfeld, PhD, Principal Investigator, Yale University


Verification Date

November 2018